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Anterior Cruciate Ligament ReconstructionNCT03336060

Neurophysiologic Correlates of Movement Planning During Complex Jump Landing Tasks and the Role of Cognitive Function

An observational study of Anterior Cruciate Ligament Reconstruction, run by Goethe University at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To examine the long-term effects of anterior cruciate ligament injuries and reconstructions (after successful rehabilitation) on cortical processes of motor planning during complex jump landing tasks and the relevance of cognitive performance measures for landing stability, respectively knee injury risk. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
What is being tested?
Cortical Correlates of Jump Landing Task
How many people
50 participants
Where
1 siteGermany
Study dates
1 Oct 2017to 30 Jun 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Study population: Cases: Healthy male participants (18 - 40 lifeyears) with unilateral ACL reconstruction and succesfull rehabilitation Controls: Healthy male participants (18 - 40 lifeyears)

Who may be able to join

  • male (18 - 40 years, right-handed)
  • sportive (preferably ball game sports, e.g. soccer)
  • Only cases:
  • unilateral, primary anterior cruciate ligament tear and reconstruction (1-10yrs ago)
  • no serious concomitant injuries (e.g. "unhappy triad")
  • no kinesiophobia
  • symmetric single leg jump performance (>85 %)

Who cannot join

  • acute injury or life-quality impairing diseases
  • any medication

Trial locations and contacts

1 site in 1 country.

Winfried Banzer, Prof contact

06979824482

Banzer@sport.uni-frankfurt.de

Florian Giesche, M.Sc. contact

06979824482

Giesche@sport.uni-frankfurt.de

Germany1 site, 1 recruiting
  • Goethe University Department of Sports Medicine

    Frankfurt am Main, Hesse, 60487

    Winfried Banzer, Prof, 06979824482, banzer@sport.uni-frankfurt.de

    Florian Giesche, M.Sc., 06979824482, Giesche@sport.uni-frankfurt.de

    Recruiting

Other trials in Germany

About this study

Official title: Long-term Effects of ACL Reconstruction Surgery on Neurophysiologic Correlates of Movement Planning During Complex Jump Landing Tasks and the Role of Neuropsychological Performance Measures: An Explorative Cross-sectional Study

To examine the long-term effects of anterior cruciate ligament injuries and reconstructions (after successful rehabilitation) on cortical processes of motor planning during complex jump landing tasks and the relevance of cognitive performance measures for landing stability, respectively knee injury risk.

Read the detailed description

Particularly, in the context of ball sports ruptures of the anterior cruciate ligament (ACL) are among the most frequent injuries. However, the ACL tear does not only result in a loss of mechanical stability in the knee joint: the tear of the ligament and the subsequent reconstructive surgery lead to a massive damage of so-called mechanoreceptors (proprioceptors). These small sensors provide the brain with precise information on the tension of the cruciate ligament and the position of the knee joint. Due to this feedback, it is possible for humans to adjust the activity of the stabilizing muscles to various situations in sports and daily life and to protect the knee from injuries. Thus, coordination deficits are common consequences after ACL-rupture and reconstruction due to the poorer sensory feedback.

New findings provide evidence that the injury-induced damage of the mechanoreceptors also causes persistent, neuronal reorganisations in the brain (injury induced neuroplasticity). These relate in particular to the motor cortex by which voluntary movements are controlled. According to the results of imaging (eg. functional magnetic resonance tomography; MRI) and electrophysiological studies (eg. Electroencephalography; EEG), these neurologic adaptation appear to persist far beyond the resumption of daily, sporting or competitive activities. Researchers suggest that these adaptations of the central nervous system might be the underlying cause of the frequently observed, persistent motor control and functional deficits (eg. muscle strength and muscle activation deficits), the relatively high re-injury, low return to sports rates and small proportions returning to their initial performance level after ACL tears and reconstruction. A pure restoration of the neuromuscular function without the elimination of the neuroplastic changes in the brain does therefore not appear sufficient.

In recent studies the effects of ACL trauma on brain activity have been investigated exclusively during unspecific, sport- and injury-unrelated tests (eg. simple flexion and extension movements and angular reproduction tasks of the knee). Often, injuries to the ACL occur under unpredictable conditions, especially in complex, dynamic movements such as changes of direction, jumps and landings. Here, the brain has to process information from the receptors of the ACL as quickly as possible to initiate an adequate motor response to protect the knee.

Against the background of the above described findings, this cross-sectional case-control study will firstly investigate the effects of completely healed ACL tears and reconstruction (side symmetry of neuromuscular performance measures above 85%) on movement planning related cortical activity (via Electroencephalography) measures during complex jump-landing tasks: The study participants perform counter-movement jumps (n=80; CMJ, flight time approximately 500 ms) followed by single leg landings. While under an anticipated condition (n=40), the individuals receive the visual information (presented on a screen) on which leg/ foot (left, right) they are required to land before self-initiated CMJs, the individuals will receive this information under the non-anticipated condition (n=40) only after take-off (approximately 400 ms before ground contact). The measurement of the landing stability is standardized by means of selected biomechanical parameters (capacitive force platform). Injury-relevant, cognitive characteristics (e.g., reaction, information processing speed and working memory) are detected by computer and paper-based clinical cognition tests.

The investigators hypothesize that the injury-related neurological adjustments in the motor cortex lead to a more intensive motor action planning before movement initiation (compensation of sensory deficits). The increased use of neuronal capacities for movement planning could subsequently lead to a slower or to unprecise motor responses to unforeseen/ non-anticipated events and subsequently cause greater landing instability, or increase the knee injury risk, respectively. It is also assumed that a lower cognitive information processing is associated with a more instable landing, or a higher risk of injury or higher injury incidence rate, respectively.

Being tested
Cortical Correlates of Jump Landing Task

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cortical Correlates of Jump Landing TaskDiagnostic test

    The study participants perform counter-movement jumps (CMJ, flight time approximately 500 ms) followed by single leg landings. While under an anticipated condition, the individuals receive the visual information (presented on a screen) on which leg/ foot (left, right) they are required to land before self-initiated CMJs, the individuals will receive this information under the non-anticipated condition only after take-off (approximately 400 ms before ground contact).

Study groups in NCT03336060
Study groupRoleWhat they receive
Healthy ControlAge matched healthy subjects. Inclusion criteria for healthy controls are: male (18 - 40 years, right-handed); sportive (preferably ball game sports, e.g. soccer); no acute injury or life-quality impairing diseases; no medication
Receives: Diagnostic Test: Cortical Correlates of Jump Landing Task
Subjects with ACL reconstructionUnilateral, primary anterior cruciate ligament tear and reconstruction (1 to 10 years ago); no serious concomitant injuries, e.g. "unhappy triad"); no kinesiophobia; symmetric single leg jump performance (>85 %); male (18 - 40 years, right-handed); sportive (preferably ball game sports, e.g. soccer); no acute injury or life-quality impairing diseases; no medication
Receives: Diagnostic Test: Cortical Correlates of Jump Landing Task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bereitschaftspotential - Movement planning associated cortical activity measures

    Determined via Electroencephalography as amplitude in microvolt [μV] and latency in milliseconds [ms] before initiation of jump movement

    Measured: Cross sectional design. Time Frame for Assessment of Movement planning associated cortical activity measures (Bereitschaftspotential, low beta-band power, frontal theta-band power) is 4 hours on one day

  2. Sensorimotor rhythm (SMR)/ low beta-band power - Movement planning associated cortical activity measures

    Determined via Electroencephalography in microvolt^2 [μV²]

    Measured: Cross sectional design. Time Frame for Assessment of Movement planning associated cortical activity measures (Bereitschaftspotential, low beta-band power, frontal theta-band power) is 4 hours on one day

  3. Frontal theta-band power - Movement planning associated cortical activity measures

    Determined via Electroencephalography in microvolt^2 [μV²]

    Measured: Cross sectional design. Time Frame for Assessment of Movement planning associated cortical activity measures (Bereitschaftspotential, SMR/ low beta-band power, frontal theta-band power) is 4 hours on one day

Secondary outcomes (19)
  1. Peak ground reaction force - Biomechanical outcome measures of single leg jump-landings

    Determined via capacitive force platform: Biomechanical outcome measure of single leg jump-landing (Newton [N])

    Measured: Cross sectional design. Biomechanical outcome measures of single leg jump-landings are assessed simultaneously with primary outcome assessment (during same 4 hours on one day)

  2. Time to stabilisation - Biomechanical outcome measures of single leg jump-landings

    Determined via capacitive force platform: Biomechanical outcome measure of single leg jump-landing (seconds [s])

    Measured: Cross sectional design. Biomechanical outcome measures of single leg jump-landings are assessed simultaneously with primary outcome assessment (during same 4 hours on one day)

  3. Center of pressure sway - Biomechanical outcome measures of single leg jump-landings

    Determined via capacitive force platform: Biomechanical outcome measure of single leg jump-landing (in millimeter [mm])^2 [μV²])

    Measured: Cross sectional design. Biomechanical outcome measures of single leg jump-landings are assessed simultaneously with primary outcome assessment (during same 4 hours on one day)

  4. Visual perceptual ability - Lower cognitive function

    Determined via pen and paper tests: Trail Making Test A (Time for task completion in seconds [s])

    Measured: Cross sectional design. Timeframe for Assessment is 5 minutes (during congnitive function assessment, separate day as primary outcome assessment)

  5. Reaction time/ processing speed - Lower cognitive function

    Determined via computer-based neuropsychological test (mean of the log10 transformed reaction times for correct responses in milliseconds [ms])

    Measured: Cross sectional design. Timeframe for Assessment is 10 minutes (during congnitive function assessment, separate day as primary outcome assessment)

  6. Working memory - Higher cognitive function

    Determined via computer-based neuropsychological test (One card learning test: Speed of performance (mean of the log10 transformed reaction times for correct responses) and Accuracy of performance (arcsine transformation of the square root of the proportion of correct responses); Digit Span Task: Number of correct reproduced digits)

    Measured: Cross sectional design. Timeframe for Assessment is 10 minutes (during congnitive function assessment, separate day as primary outcome assessment)

  7. Cognitive flexibility - Higher cognitive function

    Determined via pen and paper test: Trail-Making-Test B vs. A (time for task completion in seconds [s])

    Measured: Cross sectional design. Timeframe for Assessment is 5 minutes (during congnitive function assessment, separate day as primary outcome assessment)

  8. Inhibitory control - Higher cognitive function

    Determined via computer-based neuropsychological test: Stop-Signal-Task (Stop signal reaction time in milliseconds [ms])

    Measured: Cross sectional design. Timeframe for Assessment is 15 minutes (during congnitive function assessment, separate day as primary outcome assessment)

  9. Interference control - Higher cognitive function

    Determined via pen and paper test: Stroop-Test (Time for task completion in seconds [s])

    Measured: Cross sectional design. Timeframe for Assessment is 5 minutes (during congnitive function assessment, separate day as primary outcome assessment)

  10. Kinesiophobia (subjective measure) - Potential confounder

    Determined via questionnaire (Tampa scale)

    Measured: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)

  11. Self-reported knee function (subjective measure) - Potential confounder

    Determined via questionnaire (Lysholm knee score)

    Measured: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)

  12. Physical activities (subjective measure) - Potential confounder

    Determined via questionnaire (IPAQ)

    Measured: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)

  13. Sport activities (current and past; subjective measure) - Potential confounder

    Determined via questionnaire

    Measured: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)

  14. Risk behaviour (subjective measure) - Potential confounder

    Determined via questionnaire (DOSPERT scale)

    Measured: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)

  15. Musculoskeletal injuries (current and past; subjective measure) - Potential confounder

    Determined via questionnaire

    Measured: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)

  16. Single and both legs jump performance (objective measure) - Potential confounder

    Determined via motor testing (in centimeter [cm])

    Measured: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)

  17. Single leg jump symmetry (objective measure) - Potential confounder

    Determined via motor testing (in percent [%])

    Measured: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)

  18. Static postural control (objective measure) - Potential confounder

    Determined via motor testing (in millimeter [mm])

    Measured: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)

  19. Visuomotor reaction time (objective measure) - Potential confounder

    Determined via computer-based neuropsychological test (in milliseconds [ms])

    Measured: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2017
  2. Study start1 Oct 2017
  3. Primary completion31 May 2018 (estimated)
  4. Study completion30 Jun 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03336060
Sponsor's protocol ID
SpM2016-006
Status last verified
Mar 2018
First submitted
27 Oct 2017
Last updated
15 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Giesche F, Engeroff T, Wilke J, Niederer D, Vogt L, Banzer W. Neurophysiological correlates of motor planning and movement initiation in ACL-reconstructed individuals: a case-control study. BMJ Open. 2018 Sep 19;8(9):e023048. doi: 10.1136/bmjopen-2018-023048.

    PubMed 30232114

Questions about this trial

What is this clinical trial studying?

An observational study of Anterior Cruciate Ligament Reconstruction, run by Goethe University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Winfried Banzer, Prof (06979824482, Banzer@sport.uni-frankfurt.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bereitschaftspotential - Movement planning associated cortical activity measures (time frame: Cross sectional design. Time Frame for Assessment of Movement planning associated cortical activity measures (Bereitschaftspotential, low beta-band power, frontal theta-band power) is 4 hours on one day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03336060, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.

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